Data Indicative of Targeting Ability of BIND-014 for High Tumor Drug
Concentration

Late-Breaker Data Presented at the AACR 2012 Annual Meeting for
BIND-014, Lead Candidate from BIND’s Accurin Platform for Targeted and
Programmable Nanomedicines

AACR Annual Meeting 2012

April 04, 2012 09:00 AM Eastern Daylight Time

CAMBRIDGE, Mass.--(BUSINESS WIRE)--BIND Biosciences, a clinical-stage biopharmaceutical company developing
a new class of highly selective targeted therapeutics called Accurins™,
announced today the presentation of late-breaker clinical data for
BIND-014, the lead drug candidate within a new class of targeted
therapeutics that are programmed to concentrate at tumors, at the
American Association for Cancer Research (AACR) 2012 Annual Meeting.
BIND presented data from the ongoing Phase 1 clinical study of BIND-014,
its targeted docetaxel Accurin, in patients with solid tumors that
strongly translated from preclinical data, demonstrated safety and
tolerability, and showed evidence of anti-tumor activity with six of 17
patients with advanced or metastatic solid tumor cancers. The
preliminary Phase 1 data demonstrated partial response or stable disease
in this heavily pretreated patient population with durable responses of
up to six months in some cases. In addition, BIND-014 demonstrated
evidence of anti-tumor activity in tumors for which conventional
docetaxel is known to have minimal activity.

BIND-014 represents the first targeted and programmable Accurin
nanomedicine to reach the clinic from BIND’s proprietary drug
development platform that creates targeted therapeutics designed to
accumulate at the site of disease for high drug concentration and
maximum therapeutic effect. BIND-014 employs a combination of a targeted
biodegradable nanoparticle and docetaxel, a proven cancer drug. The
ongoing Phase 1 study has reached a dose of 75 mg/m2 with
dose escalation continuing and BIND-014 continues to be well-tolerated
in the study.

“The early clinical activity observed with BIND-014 in patients with
advanced or metastatic solid tumor cancers is encouraging,” commented
Daniel D. Von Hoff, M.D., F.A.C.P., Principal Investigator for the study
and Physician-in-Chief and Distinguished Professor at the Translational
Genomics Research Institute (TGen) and Chief Scientific Officer for US
Oncology and the Scottsdale Clinical Research Institute. “There is a
critical need for targeted treatment options for patients with difficult
to treat solid tumors and we look forward to further evaluating the
potential of BIND-014.”

“The emerging BIND-014 clinical data are showing exciting signals of
activity, validating the potential for the revolutionary impact of
nanomedicines for the treatment of cancer,” commented Philip W. Kantoff,
MD, Chief Clinical Research Officer, Dana-Farber Cancer
Institute, and Professor of Medicine, Harvard Medical School.
“What’s equally exciting is that I have never witnessed a potentially
revolutionary technology go from concept to human clinical testing as
rapidly as BIND-014, and this is credit to the world-class team of
scientists, engineers, physicians, for-profit and non-profit
organizations that have converged to advance this technology.”

In a late-breaking poster presentation entitled “A Phase 1, Open Label,
Safety, Pharmacokinetic and Pharmacodynamic Dose Escalation Study of
BIND-014 Given by IV Infusion to Patients with Advanced or Metastatic
Cancer,” BIND presented clinical data consistent with preclinical
observations in which drug concentration at the tumor site and efficacy
in multiple tumor types was demonstrated:

Preliminary evidence of anti-tumor activity during dose escalation
with evidence of anti-tumor activity in six of the 17 patients treated
ranging from one durable confirmed partial response (cervical cancer)
and five with stabilization of disease (pancreatic, colorectal, bile
duct, tonsillar and anal cancer).

Evidence of antitumor activity in cancers in which conventional
docetaxel has minimal activity.

At all dose levels studied, with 75 mg/m2 reached to date,
BIND-014 was generally well-tolerated with no new toxicities observed.
Dose escalation continues.

Strong translation of pharmacokinetic data from preclinical findings
to Phase 1 clinical data with highly differentiated PK profile from
conventional docetaxel and strong dose linearity across doses. The
clinical results are consistent with the preclinical findings that
BIND-014 concentrates drug activity in the tumor resulting in improved
efficacy.

“We are very pleased with these data as our ongoing clinical study with
BIND-014 lays a strong foundation to advance into Phase 2 development
later this year. In addition, these data show the emerging potential of
BIND-014 to be a significant new cancer therapy for patients by
fundamentally changing the pharmacology of docetaxel allowing it to
differentially concentrate in the tumors by up to ten-fold, as shown in
our preclinical models, for better clinical efficacy across multiple
cancers including those in which conventional docetaxel has minimal
activity,” said Scott Minick, President and Chief Executive Officer of
BIND Biosciences. “BIND-014 is the clinical validation of BIND’s Accurin
technology platform, and marks an important milestone for the field of
nanomedicine, BIND and, most importantly, patients.”

The Phase 1 study has an ascending, intravenous dose design. The
objectives of the study are to determine the safety, tolerability and
maximum tolerated dose of BIND-014 and to assess preliminary evidence of
antitumor activity. This clinical study is being conducted at the
Virginia G. Piper Cancer Center at Scottsdale Healthcare in Scottsdale,
Arizona, in collaboration with the Translational Genomics Research
Institute and the Scottsdale Healthcare Research Institute, the Karmanos
Cancer Institute in Detroit, Michigan, and Marin Specialty Care in
Greenbrae, California.

About BIND-014

BIND-014 is a programmable nanomedicine that combines a targeting ligand
and a therapeutic nanoparticle. BIND-014 contains docetaxel, a proven
cancer drug which is approved in major cancer indications including
breast, prostate and lung, encapsulated in FDA-approved biocompatible
and biodegradable polymers. BIND-014 is targeted to prostate specific
membrane antigen (PSMA), a cell surface antigen abundantly expressed on
the surface of cancer cells and on new blood vessels that feed a wide
array of solid tumors. In preclinical cancer models, BIND-014 was shown
to deliver up to ten-fold more docetaxel to tumors than an equivalent
dose of conventional docetaxel. The increased accumulation of docetaxel
at the site of disease translated to marked improvements in antitumor
activity and tolerability. BIND-014 is currently in Phase 1 human
clinical testing in cancer patients with advanced or metastatic solid
tumor cancers (NCT01300533). The early development of BIND-014 was
funded in part by the National Cancer Institute and the U.S. National
Institutes of Standards and Technology (NIST) under its Advanced
Technology Program (ATP).

About BIND Biosciences

BIND Biosciences is a clinical-stage biopharmaceutical company
developing a new class of highly selective targeted and programmable
therapeutics called Accurins™. BIND’s Medicinal Nanoengineering™
platform enables the design, engineering and manufacturing of Accurins
with unprecedented control over drug properties to maximize trafficking
to disease sites, dramatically enhancing efficacy while minimizing
toxicities.

BIND is developing a pipeline of novel Accurins that hold extraordinary
potential to become best-in-class drugs and improve patient outcomes in
the areas of oncology, inflammatory diseases and cardiovascular
disorders. BIND's lead product candidate, BIND-014, is currently in
Phase 1 clinical testing in cancer patients and is designed to
selectively target a surface protein upregulated in a broad range of
solid tumors. BIND also develops Accurins in collaboration with
pharmaceutical and biotechnology partners to enable promising pipeline
candidates to achieve their full potential and to utilize selective
targeting to transform the performance of important existing drug
products.

BIND is backed by leading investors, Polaris Venture Partners, Flagship
Ventures, ARCH Venture Partners, NanoDimension, DHK Investments,
EndeavourVision and Rusnano. BIND was founded on proprietary technology
from the laboratories of two leaders in the field of nanomedicine,
Professors Robert Langer, Sc.D., David H. Koch Institute Professor of
the Massachusetts Institute of Technology (MIT) and Omid Farokhzad,
M.D., Associate Professor of Harvard Medical School. For more
information, please visit the company's web site at www.bindbio.com.